(Fighting against New Coronary Pneumonia) Omicron Variant New Coronary Virus Inactivated Vaccine Obtained Clinical Approval from the State Food and Drug Administration of China

  China News Agency, Beijing, April 26. Sinopharm Group's China Bio-Omicron variant (hereinafter referred to as the Austrian strain) new coronavirus inactivated vaccine received clinical approval from the China National Medical Products Administration on the 26th.

  On the basis of the prototype inactivated vaccine for the new crown that has been marketed in the early stage and the completion of the research and development of beta and delta variant inactivated vaccines, Sinopharm Group China Biotech introduced the Omicron variant strain from the University of Hong Kong for the first time, December 9, 2021 Japan quickly started the research and development of the inactivated vaccine of the Austrian strain.

  According to the guiding principles and research and development strategies of the improved new crown vaccine of the State Food and Drug Administration, Sinopharm China Biotechnology has completed the screening, passage and expansion of the Austrian strain by using the newly built P3 high-level biosafety laboratory, and established a three-level virus species. The library has completed process verification, preparation of multiple batches of large-scale products, quality standard research, safety evaluation in animals and immunogenicity research. The results show that the inactivated vaccine of the new crown of the Austrian strain can produce high droplets against the Austrian strain and various variant strains. Neutralizing antibodies.

  On March 3, 2022, the Beijing Institute of Biological Products, the Wuhan Institute of Biological Products and the Hong Kong research institute determined the clinical plan and related details. The clinical application materials were submitted to the Hong Kong Department of Health on April 1, the ethics approval was obtained on April 12, and the clinical research approval was obtained on April 13, making it the world's first inactivated Chronomicron vaccine approved for clinical use.

  At the same time, Sinopharm Group China Biotech started to submit domestic clinical application materials to the Drug Evaluation Center of the State Food and Drug Administration on a rolling basis from January 26, and started the technical review.

  On April 26, China Bio-Beijing Institute of Biological Products received clinical approval from the National Medical Products Administration of China for its Omicron variant of the new coronavirus inactivated vaccine.

Sino Bio will use a randomized, double-blind, cohort study to conduct a sequential immunization clinical study in people aged 18 and over who have completed 2 or 3 doses of the new crown vaccine to evaluate the inactivated vaccine against the new coronavirus of the Omicron variant safety and immunogenicity.

  It is reported that Sino Bio has independently developed 4 new crown diagnostic reagents, 4 new crown specific treatment drugs and successfully developed 4 new crown vaccines on three technical routes in the three fields of "diagnosable, curable and preventable".

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